Sr Spec, IT
1 week ago
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
About Us
Nothing changes if nothing changes, which is why Baxter is transforming our global IT function—into one that will strengthen partnerships and enable smarter, more efficient and connected business processes. In the dynamic healthcare industry, we need to be ready to face new challenges and opportunities. As we learn, we must be agile and innovative to reveal new ways of working. Technology and our digital capability will help create a more efficient and innovative ecosystem to enable our employees, customers and products to drive better outcomes for patients worldwide.
We are at the critical intersection where robust IT infrastructure and networking support meets the physicians, nurses and care givers who save and sustain lives. Together, we can build upon Baxter’s rich heritage to advance the next generation of transformative healthcare innovations. Together, we can change how IT meets healthcare. Together, we are Baxter.
This is where technology fuels purpose-driven work. Where your purpose accelerates our mission.
Title: Spec, IT – Validation Lead
Location: Bangalore
Your Role
This position is accountable for leading and performing activities in support of the validation and compliance of a computerized system to ensure system meets its intended use. This position will work with IT team(s) to ensure a computerized system is compliant with applicable regulations (21 CFR Part 11, GxP Regulations) and Baxter Quality Management System requirements.
Support the Validation activities during the deployment of any new GxP Application.
What you’ll be doing
Review project teams' work to ensure quality (design walk-through, code review, test results, etc.) and alignment to the processes, standards, and regulatory requirements.
Responsible for the conduct of Verification and Validation activities as per requirements defined in Baxter Design Control Method and regulatory requirements.
Responsible for assuring the new Computerized System meets the requirements of the systems users & Regulatory requirements.
Creating, managing, and /or maintaining the documents required by Baxter quality systems procedures for the development and validation of the Computerized System.
Responsible for oversight of Validation protocol authoring and execution.
Application compliance assessment and fitment with applicable regulation and Baxter Procedures.
Shall control the Validation Package and shall ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures.
Implementation of Risk based methodologies in GxP Validation lifecycle and Change Management for ERP system (JDE, GME, WMS, WCS).
Responsible for ERP rollouts and implementation using scalable lifecycle approach.
Coordinate risk management of new or changed computerized Systems.
Ensure design review and application acceptance including completeness of Trace Matrix (link among user requirements, functional requirements, design requirements and test plan)
Communicate and control the adherence to validation standards by the team.
Provide support to the functional team/users for the development of validation deliverables (functional specification, technical specification, system & user procedures, etc).
Support the processes to maintain in a controlled state of validation during the entire life cycle of Computerized Systems.
What you’ll bring
Bachelor’s degree in science, engineering, or technology and meaningful work experience required.
5+ years of Quality or IT system development experience is required.
Thorough knowledge of GxP regulations (e.g. 21 CFR Part 11, GAMP-5, MHRA etc.), Standards, and Industry Best Practices.
Knowledge of data privacy regulation;
Good communication skills and strong stakeholder management.
Basic project management skills
Strong knowledge of software development/implementation processes.
Excellent technical writing skills
Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
Knowledge and experience in the following areas:Documentation Management using document management tool.Test Management tool Micro Focus ALMAgile Scrum PrincipleCHG CTRL management in IT Now/TW8
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